OSTEOGEN SBRG

K033098 · Impladent , Ltd. · LYC · Apr 27, 2004 · Dental

Device Facts

• Record ID: K033098
• Device Name: OSTEOGEN SBRG
• Applicant: Impladent , Ltd.
• Product Code: LYC · Dental
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As an aid in sinus augmentation (sinus lift) procedures. As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects. As an aid in the treatment of periapical and periodontal defects.

Device Story

OsteoGen (SBRG) is a bone graft material used by dental surgeons in clinical settings. It serves as an aid in oral surgical procedures including sinus lifts, tooth socket augmentation, and repair of alveolar ridge, periapical, and periodontal defects. The device is applied directly to the surgical site to facilitate bone regeneration or augmentation. It functions as a scaffold or filler to support bone healing in dental defects. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Bone graft material (SBRG). Specific material composition and ASTM standards not provided in the document. Device is a physical graft material; no software or electronic components.

Indications for Use

Indicated for patients requiring bone grafting procedures in dentistry, specifically for sinus augmentation, tooth socket augmentation, alveolar ridge deformity treatment, peri-implant alveolar defect repair, and treatment of periapical and periodontal defects.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Impladent, Limited Mr. Maurice Valen President & Director, Research Development 198-45 Foothill Avenue Holliswood, New York 11423

Re: K033098

Trade/Device Name: OsteoGen® (SBRG) Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: February 26, 2004 Received: February 27, 2004

Dear Mr. Valen:

We have reviewed your Section 510(k) promarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Valen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-46. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Shih-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K033098

Page 1 of 1

510(k) Number (if known): K033098

Device Name: OsteoGen® (SBRG)

Indications for Use:

As an aid in sinus augmentation (sinus lift) procedures.

As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects.

As an aid in the treatment of periapical and periodontal defects.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mellville for MSR

Prescription Use (Per 21 CFR 801.109) Infection (

510(k) Number: K033044